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RecruitingNCT05752149STELLARUpdated Sep 14, 2026

Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial

A Phase 2 interventional study of CRGD-ZW800-1 in Squamous Cell Carcinoma of the Larynx and Squamous Cell Carcinoma of the Hypopharynx, sponsored by Erasmus Medical Center. Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Erasmus Medical Center · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is an open-label, single-dose, prospective clinical trial. The study comprises 2 work packages. The main objective of work package I (WP-1) is to assess feasibility of Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose of the cRGD-ZW800-1. Work package II (WP-II) is designed to assess whether FLI can detect and decrease tumor positive margins after a TLE.

Read the detailed description

This is a two staged clinical trial to investigate intraoperative fluorescence imaging in patientsundergoing TLE. WP-I is a dose finding study in which 2 doses will be tested with a possibility of a third dosing group. Every dosing cohort comprises 3 patients. After WP-I, an interim analysis will be performed to decide the optimal dose.

The optimal dose will be based on the TBR and the performance in detecting the most close margin (i.e. 'the sentinel margin'). A TBR of at least 1.5 is required for the optimal dose. If a positive margin is missed with fluorescence imaging, the concerned dose will be defined as suboptimal.

WP-II is an extension cohort of the optimal dose cohort selected in WP-I. WP-II will comprise of 18 patients.

The endpoints for WP-II are:

  • the rate of tumor free resection margins based on the current golden standard;
  • Sensitivity, specificity and positive predictive value of FLI;
  • The intraoperative change in surgical management based on FLI;
  • FLI of excised cervical lymph nodes;
  • Influence of previous radiotherapy on the FLI performance;
  • Adverse events and toxicity after intravenous injection with cRGD-ZW800-1;
02

Conditions studied

  • Squamous Cell Carcinoma of the Larynx
  • Squamous Cell Carcinoma of the Hypopharynx

Keywords

  • Tumour specific fluorescence imaging
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with biopsy-proven squamous cell Laryngeal and hypopharyngeal cancer, eligible for surgical resection of the tumor by TLE;
  • ≥ 18 years of age;
  • Written informed consent must be obtained;
  • Sufficient knowledge of the Dutch language to understand the informed consent form;

Exclusion criteria

Exclusion Criteria:

  • History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent;
  • Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal, squamous cell skin carcinoma, or other head- and neck squamous cell cancer;
  • Patients pregnant or breastfeeding;
  • Patients with renal insufficiency (defined as eGFR \< 60);
  • Patients with previous kidney transplantation or a solitary functioning kidney;
  • Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors), that cannot be paused during the course of the study;
  • Patients with ASA classification of 4 or higher;
  • Patients with measured QTc of 500 ms or higher at screening;

  • Patients with laboratory abnormalities defined as:

    • Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
    • Total bilirubin above 3 times the ULN or;
    • Platelet count below 100 x 109/L or;
    • Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males).
  • Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a preexisting disease or concomitant medications;
04

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Care provider)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    0.05 mg/kg cRGD-ZW800-1

    n=3. Injection of 0.05 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery

    Drug: CRGD-ZW800-1

  • Experimental
    0.025 mg/kg cRGD-ZW800-1

    n=3. Injection of 0.025 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery

    Drug: CRGD-ZW800-1

  • Experimental
    0.01 mg/kg cRGD-ZW800-1

    n=3. Injection of 0.01 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery.

    Drug: CRGD-ZW800-1

  • Experimental
    Expansion Cohort

    n=18: expansion cohort will be added to the group of patients that had received the selected dose in WP-I.

    Drug: CRGD-ZW800-1

Interventions

  • DrugCRGD-ZW800-1

    Intravenous administration of study drug at lesat 2h prior to surgery

05

What researchers measure

Primary outcomes

  1. WP-I: the optimal dose of cRGD-ZW800-1 for FLI of laryngeal and hypopharyngeal cancer

    Based on the tumor-to-background ratio (TBR) on breadloaves. Higher TBRs indicate a better outcome

    Time frame: Up to 48 hours after administration (Depending on pathology grossing)

  2. WP-II: the rate of clear tumor resection margins

    Time frame: Through histopathology, up to max 4 weeks post-op

06

Study locations

1 of 2 sites recruiting
  • Erasmus Medical Center
    Rotterdam, South Holland 3015GD, Netherlands
    • Stijn Keereweer, MD, PhD · Contact
    Not yet recruiting
  • Erasmus Medical Center
    Rotterdam, South Holland 3015GD, Netherlands
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — Uponr reasonable reasonable request

08

Registry details

Key details

Study ID
NCT05752149
Lead sponsor
Erasmus Medical Center
Responsible party
Stijn Keereweer (Otorhinolaryngologist, Head and Neck Surgeon, MD, PhD, Erasmus Medical Center) — Principal investigator
First posted
Mar 2, 2023
Start date
Mar 31, 2026
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Sep 14, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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